MiniMed-780G 1 Safety and Indications

Conventions

Convention           Definition

 

Select                      Press  to activate a screen item, accept a value, or initiate an action.

Select and hold       Press and hold  to perform an action. Press          Press and release a button.

Press and hold         Press and hold a button.

Bold text                 Indicates screen items and buttons, such as “Select Next to continue.”

X                             Indicates a value that might appear differently on the pump screen.

Note                       Note: A note provides helpful information.

Pump

•     Do not use the pump in the presence of anesthetic mixtures that include oxidizing agents such as oxygen or nitrous oxide. Exposure to these conditions may damage the pump and result in serious injury.

•     Always use the fingertip for blood samples when entering a BG meter reading into the pump while using the SmartGuard feature. Blood samples from other locations, such as the palm or forearm, have not been studied for use with the SmartGuard feature, and the accuracy of these samples is unknown.

•     When the SmartGuard feature is active, SG readings are used to calculate basal insulin delivery and correction boluses. Do not use SG readings to make treatment decisions while the pump is in Manual mode. SG and BG values may differ. Sensor performance may occasionally vary from sensor to sensor and in different situations for a sensor, such as on the first day of use.

A BG meter reading is required in the following situations:

–    Before a correction bolus is given in Manual mode.

–    The SG reading is lower than expected.

–    The SG reading is higher than expected.

–    Suspected hypoglycemia or symptoms of hypoglycemia.

–    Suspected hyperglycemia or symptoms of hyperglycemia.

–    Suspected diabetic ketoacidosis or symptoms of diabetic ketoacidosis.

Do not use SG readings to make treatment decisions while the pump is in Manual mode.

 

•     The low SG alert functionality is distinct from the automated insulin dosing function of the MiniMed 780G system. When using the SmartGuard feature, the MiniMed 780G system has been shown to be safe and effective for its intended use in this population. However, do not rely solely on the use of the Low SG alarm, or the use of “Alert on Low” and “Alert before Low” when those alerts are set at or below 60 mg/dL. At these BG levels, a low SG alarm or alert may not reflect the user’s true BG, and you may not be notified. Do not ignore symptoms of low glucose. Always confirm SG readings with a BG meter, and treat according to the recommendation of a healthcare professional. Solely relying on these SG alerts and readings for treatment decisions could result in missing severe hypoglycemia (low BG) events.

•     Do not rely on the pump tones or vibrations to navigate the pump screens or menus. Relying on pump tones or vibrations may result in incorrect menu or setting selection. Always view the pump screen when selecting menus and entering information into the system.

•     Only use rapid-acting U-100 insulin (Humalog™* and NovoLog™*) prescribed by a healthcare professional for use with an infusion pump. Use of any other drug or medication in the reservoir can cause serious injury.

•     Confirm that the infusion set is disconnected from the body before rewinding the pump or filling the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to the body. Doing so may result in an accidental infusion of insulin, which may cause hypoglycemia.

•     Do not insert the reservoir before rewinding the pump. Doing so may result in an accidental infusion of insulin, and may result in hypoglycemia.

•     Do not use the MiniMed 780G insulin pump or additional system devices next to other electrical equipment, which may cause interference. This includes mobile communication devices such as cell phones that are not paired with the MiniMed 780G system, GPS navigation systems, anti-theft systems,

radio-frequency identification (RFID) systems, and any electrical equipment that has an output transmitter power greater than 1 W. The recommended separation distance between the insulin pump and common RF emitters is 12 in (30 cm). For more information about recommended separation distance guidelines between the insulin pump and common RF emitters, see Guidance and manufacturer’s declaration, page 340. Other electrical equipment that may compromise normal system operation has been contraindicated. For more information, see Exposure to magnetic fields and radiation, page 52.

•     Do not unscrew or retighten the tubing connector on the reservoir while the infusion set is connected to the body. Doing so may result in an accidental infusion of insulin, and may cause hypoglycemia.

•     Do not use standard Luer sets with the MiniMed 780G system. Only use MiniMed or Medtronic reservoirs and infusion sets that are specifically designed for use with the MiniMed 780G system.

•     Do not change or modify the MiniMed or Medtronic reservoir and infusion set. Modification of these components may cause serious injury, interfere with device operation, and void the warranty.

•     Do not rely on preset pump alarms or reminders alone to check BG levels. Set additional reminders on other devices, such as a cell phone.

•     Do not change or modify the internal RF transmitter or antenna. Doing so may interfere with the safe operation of the equipment.

•     The MiniMed 780G system is approved for use with the Guardian 4 transmitter with Bluetooth™* wireless technology (MMT-7841). Use of a transmitter not approved for communication with the pump may cause damage to system components and may result in inaccurate SG readings.

•     If other devices that employ radio frequencies are in use, such as cell phones that are not paired with the MiniMed 780G system, cordless phones, walkie-talkies, and wireless networks, they may prevent communication between the transmitter and the insulin pump. This interference does not cause any incorrect data to be sent and does not cause any harm to devices. Moving away from, or turning off, these other devices may enable communication. Contact 24-Hour Technical Support if RF interference continues.

•     Special Precautions regarding Electromagnetic Compatibility (EMC): This

body-worn device is intended to be operated within a residential, domestic, public or work environment, where common levels of radiated “E” (V/m) or “H” fields (A/m) exist. Technologies that emit these fields include: cellular phones that are not paired with the MiniMed 780G system, wireless technology, electric can openers, microwaves, and induction ovens. The MiniMed 780G system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the provided instructions, may cause harmful interference to radio communications.

•     Portable and mobile RF communications equipment can affect the operation of the MiniMed 780G system. If interference occurs, move away from the RF transmitter.

•     The MiniMed 780G insulin pump can generate, use, and radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. If the MiniMed 780G insulin pump does cause interference to radio or television reception, try to correct the interference by one or more of the following measures:

–    Decrease the distance between the transmitter and the insulin pump to 6 feet (1.8 meters) or less.

–    Decrease the distance between the meter and the insulin pump to 6 feet (1.8 meters) or less.

–    Increase the separation between the transmitter and the device that is receiving/emitting interference.

•     The safety of the MiniMed 780G system has not been studied in persons with impaired kidney function. Persons with kidney disease should consult a healthcare professional to determine if the potential benefits of pump therapy outweigh the risks.

•     Monitor for diabetic retinopathy. During the beginning of insulin pump therapy, rapid improvement in glucose control and reduction in A1c may result in worsening of existing diabetic retinopathy. Use of the MiniMed 780G system has been associated with rapid improvement in glucose control. Monitor for diabetic retinopathy with retinal eye examinations and if necessary adequate treatment must be performed by a healthcare professional before beginning a treatment with the MiniMed 780G insulin pump.

•     The safety of the MiniMed 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. Persons in these situations should consult a healthcare professional to determine if the potential benefits of pump therapy outweigh the risks.

•     The safety of using the Suspend before low and Suspend on low features in patients who have no pump experience is not known. The Suspend before low and Suspend on low features should not be used if insulin pump settings have not been previously established. Insulin pump settings include basal rates, insulin to carb ratio, and insulin sensitivity factors. Consult a healthcare professional before using the Suspend before low or Suspend on low features.

•     If a serious incident related to the device occurs, immediately report the incident to a healthcare professional. Serious incidents may include death, temporary or permanent serious decline in health, or a serious public health threat. For healthcare professionals, immediately report any serious incident to the applicable competent authority.

•     The user must have adequate vision and hearing in order to recognize all functions of the pump, including alerts, alarms, and reminders. Not recognizing an alert, alarm, or reminder could result in a hypoglycemic or hyperglycemic event.

Reservoir and infusion sets

See the user guides that came with the device for the most current warnings related to the reservoir and infusion set.

•     If insulin, or any other liquid, gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly fill the infusion set. This may result in the infusion of too little or too much insulin, and may result in hyperglycemia or hypoglycemia. If this occurs, start over with a new reservoir and infusion set.

•     Do not reinsert the introducer needle into the infusion set. Reinsertion may cause tearing of the soft cannula, which may cause unpredictable insulin delivery, and may result in hypoglycemia or hyperglycemia.

•     If a BG reading is unexpectedly high during the infusion of insulin or if an occlusion alarm occurs, check the infusion set for clogs and leaks. If in doubt, change the infusion set in case the soft cannula is dislodged, crimped, or partially clogged. Consult a healthcare professional to create a plan for rapid insulin replacement in the event this occurs. Check BG to confirm that the appropriate amount of insulin has been administered.

•     Do not reuse the infusion set. Reuse of the infusion set may damage the cannula or needle, and lead to infection, site irritation, and inaccurate insulin delivery.

•     Dispose of the transfer guard safely in a sharps container.

•     Do not fill the infusion set tubing or attempt to free a clogged line while the set is inserted into the body. Filling the infusion set tubing while it is connected to the body may cause an unintended infusion of insulin, and result in hypoglycemia.

•     Keep the infusion set away from contact with disinfectants, perfumes, or deodorant. These products may affect the integrity of the infusion set, and result in inaccurate insulin delivery and cause hypoglycemia or hyperglycemia.

•     Do not clean, reuse, or re-sterilize the infusion set and introducer needle. Reuse of the infusion set or introducer needle can lead to infection, insulin degradation, and inaccurate insulin delivery. Always dispose of the infusion set and introducer needle directly in a sharps container after use.

•     Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight, inside a vehicle, or in other environments subject to excessive heating.

•     Only use reservoir and infusion sets manufactured or distributed by Medtronic Diabetes. The pump has been tested to operate when used with compatible reservoirs and infusion sets. Medtronic Diabetes cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third parties. Medtronic Diabetes is not responsible for any injury or pump malfunction that may occur in association with the use of incompatible components.

•     Always wash hands with soap and water before temporarily disconnecting the infusion set. Consult a healthcare professional for ways to compensate for missed insulin while the infusion set is disconnected to prevent hyperglycemia.

•     Monitor BG levels when the infusion set is disconnected, and after the infusion set is reconnected to the body.

•     Do not clean, reuse, or re-sterilize the reservoir or transfer guard after use. The reservoir and transfer guard are sterile, non-pyrogenic, and for single use only. Reusing the reservoir or transfer guard may lead to insulin degradation, infection, inaccurate insulin delivery, and may damage the pump.

•     Always follow the instructions for insertion of the infusion set. Improper insertion of the infusion set or improper maintenance of the infusion site can result in infection and inaccurate insulin delivery.

•     If using the infusion set for the first time, perform the first set-up in the presence of a healthcare professional.

•     Before use, fill the infusion set tubing to remove all air from the set.

•     Do not use the insulin, infusion set, and reservoir longer than the duration of use indicated. Check the corresponding user guide or labeling for more information. Replace the insulin, infusion set, and reservoir according to the shortest duration of use indicated. Using the insulin, infusion set, or reservoir longer than the indicated duration of use can increase the risk of set occlusions and cause problems with insulin absorption, which can lead to severe hyperglycemia and diabetic ketoacidosis.

•     Do not change the infusion set just before bedtime without checking BG one to three hours after insertion.

•     Confirm sterility by checking that the sterile paper and tamper-proof seal are not damaged.

•     The infusion set is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use if the package has been opened or damaged, or if the tubing connector needle is damaged. If the package has been opened or damaged, or if there is damage to the infusion set, start over with a new infusion set.

•     Before insertion, clean the insertion site with isopropyl alcohol.

•     Check frequently to confirm that the soft cannula remains firmly in place. If the soft cannula becomes dislodged or is improperly inserted, the full amount of insulin may not be delivered, which may result in hyperglycemia.

 

•     When unwinding MiniMed Mio infusion set tubing, use caution as a hard pull of the tubing can result in damage to the infusion set and introducer needle. Confirm that the infusion set is properly in place when the tubing is fully released.

•     If the infusion site becomes inflamed, replace the set and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose or if the soft cannula becomes fully or partially dislodged from the skin.

•     Check the infusion set to confirm that no air bubbles are present in the tubing. Air in the tubing may result in inaccurate insulin delivery, and result in hyperglycemia.

•     Never point a loaded insertion device towards a body part where insertion is not desired.

•     Remove the needle guard before inserting the infusion set.

Sensor and serter

For the most current warnings, see the user guide that came with the device.

•     Do not attempt to connect a transmitter that is not compatible with the sensor. The sensor is designed to work with approved transmitters only. Connecting the sensor to a transmitter that is not approved for use with the sensor may damage the components.

•     Consult a healthcare professional if a medication that contains acetaminophen or paracetamol is taken while wearing the sensor. Medications that contain acetaminophen or paracetamol can falsely raise sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen or paracetamol active in the body and can differ for each person. Falsely elevated sensor readings can result in over-delivery of insulin, which can cause hypoglycemia. Medications that contain acetaminophen or paracetamol include, but are not limited to, cold medicines and fever reducers. Check the label of any medications being taken to see if acetaminophen or paracetamol is an active ingredient. Use additional blood glucose meter readings to confirm blood glucose levels.

While the SmartGuard feature is active, if acetaminophen or paracetamol is taken, program a temp target for up to eight hours, or the amount of time recommended by a healthcare provider. For more information, see Setting a temp target, page 196. Use blood glucose values instead of sensor glucose readings to calculate a meal bolus or correction bolus for up to eight hours, or the duration recommended by a healthcare provider, after taking acetaminophen or paracetamol.

•     Always inspect the packaging for damage prior to use. Sensors are sterile and non-pyrogenic, unless the package has been opened or damaged. If the sensor packaging is open or damaged, discard the sensor directly into a sharps container. Use of a non-sterile sensor may result in infection at the insertion site.

•     Instructions for using the One-press serter (MMT-7512N) are different from other Medtronic insertion devices. Failure to follow directions, or using a different serter, may result in improper insertion, pain, or injury.

•     Confirm that the sensor is securely placed in the serter to avoid improper insertion, pain, or minor injury.

•     Do not allow children to put small parts in their mouth. This product poses a choking hazard for young children.

•     Healthcare professionals and caregivers:

–    Always wear gloves to insert the sensor. A retractable needle is attached to the sensor. Minimal bleeding may occur.

–    Cover the sensor with sterile gauze to remove the needle housing from the sensor.

•     Place the needle housing directly into a sharps container after sensor insertion to prevent accidental needle stick injury.

•     Watch for bleeding at the insertion site (under, around, or on top of the sensor). If bleeding occurs, do the following:

1.    Apply steady pressure, using sterile gauze or a clean cloth placed on top of the sensor, for up to three minutes. The use of unsterile gauze can cause site infection.

2.   If bleeding stops, connect the transmitter to the sensor. If bleeding does not stop, do not connect the transmitter to the sensor because blood can get into the transmitter connector, and may damage the device.

•     If bleeding continues, causes excessive pain or discomfort, or blood is significantly visible in the plastic base of the sensor, do the following:

 

1.    Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container.

2.   Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from a healthcare professional.

3.   Insert a new sensor in a different location.

•     Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood. Minimal bleeding may occur. Contact with patient blood can cause infection.

•     Never point a loaded serter toward any body part where insertion is not desired. An accidental button-push may cause the needle to inject the sensor in an undesired location and cause minor injury.

•     The safety of sensor use in critically ill patients is not known. Sensor use in critically ill patients is not recommended.

Transmitter

See the user guide included with the device for the most current warnings related to transmitter use.

•     Always refer to the sensor user guide for all precautions, warnings, and instructions related to the sensor. Not referring to the sensor user guide can result in serious injury or damage to the sensor.

•     Do not allow children to put small parts in their mouth. This product may pose a choking hazard that can result in serious injury or death.

•     Do not change or modify the device. Modifying the device can cause serious injury, interfere with the ability to operate the device, and void the warranty.

•     Do not use the tester if it comes into contact with blood. Contact with blood may cause infection. If the tester comes into contact with blood, dispose directly into a sharps container.

•     Bleeding may occur after inserting the sensor. Always make sure that the site is not bleeding before connecting the transmitter to the sensor. Blood can get into the transmitter connector and damage the device. Discard the device if damaged. If bleeding occurs, apply steady pressure with a sterile gauze, pad, or clean cloth at the insertion site until bleeding stops. After bleeding stops, connect the transmitter to the sensor.

•     Do not discard the transmitter in a medical waste container or expose it to extreme heat. The transmitter contains a battery that may ignite and result in serious injury.

•     Do not use the transmitter next to other electrical equipment that may cause interference. This includes mobile communication devices such as cell phones, GPS navigation systems, and other devices that have an output transmitter power greater than 1 W. Other electrical equipment that may compromise normal system operation has been contraindicated.

Meter

For the most current warnings, see the User’s Manual that came with the device.

Always use the fingertip for blood samples when entering a BG meter reading into the pump while using the SmartGuard feature. Blood samples from other locations, such as the palm or forearm, have not been studied for use with the SmartGuard feature, and the accuracy of these samples is unknown.

Limitations

•     Do not use the meter at high hematocrit levels above 65% or low hematocrit levels below 10%.

•     Not for use in diagnosis or screening of diabetes mellitus.

•     Not for neonatal use.

•     Abnormally high concentrations of ascorbic acid (vitamin C) resulting in blood concentrations in excess of 5 mg/dL may cause inaccurate test results. If you are not sure please check with your doctor.

•     Do not use the meter system to measure blood glucose in people who are experiencing cardiovascular collapse (severe shock) or decreased peripheral blood flow.

•     Do not use this system during xylose absorption test.

•     Not for use on critically ill patients, patients in shock, dehydrated patients, or hyperosmolar patients.

•     This system has not been tested at altitudes higher than 10,150 feet.

CAUTION: Every BG reading provided to the pump is used to calibrate the sensor. Do not use Alternative Site Testing to calibrate a continuous glucose monitoring system. Do not use Alternative Site Testing to make insulin dosing calculations.

Potential Biohazard

•     During normal testing, any blood glucose meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne pathogens, even after you have performed cleaning and disinfecting.1,2

•     The meter and lancing device should never be used by more than one person. Do not share the meter and lancing device with anyone, including family members, due to the risk of infection from bloodborne pathogens.1,2 Do not use on multiple patients!

•     Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all, bloodborne pathogens.3

1 FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/29/2010.” http://wayback.archive-it.org/7993/20161022010458/ http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.

Accessed January 17, 2018.

2 CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens (2010).” http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html. Accessed January 17, 2018.

3 Centers for Disease Control and Prevention (CDC): “Guideline for Disinfection and Sterilization in healthcare Facilities, 2008.” Update: May 2019. William A. Rutala, Ph.D., M.P.H.,

•     If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person.

•     Disinfect the meter and lancing device before allowing anyone else to handle them. Do not allow anyone else to test with the meter or lancing device.

•     It is important to keep the meter and lancing device clean and disinfected. For instructions on how to clean and disinfect the meter and lancing device, see the chapter Meter and Lancing Device Cleaning and Disinfecting.

•     Wash hands and dry thoroughly before and after handling the meter, lancing device, or test strips.

Exposure to magnetic fields and radiation

•     Do not expose the pump, transmitter, or sensor to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields (for example, x-ray, CT scan, or other types of radiation). Strong magnetic fields can cause the system to malfunction, and result in serious injury. If the pump is exposed to a strong magnetic field, discontinue use and contact 24-Hour Technical Support for further assistance.

Magnetic fields, and direct contact with magnets, may affect the accurate functioning of the system which may lead to health risks such as hypoglycemia or hyperglycemia.

•     Remove the pump, sensor, transmitter, and meter before entering a room with x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate vicinity of this equipment can make the devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.

•     Do not expose the pump to a magnet, such as pump cases that have a magnetic clasp. Exposure to a magnet may interfere with the motor inside the pump. Damage to the motor can cause the device to malfunction, and result in serious injury.

•     Do not send the pump or transmitter through an x-ray scanning machine. The radiation can damage the pump components that regulate insulin delivery, and may result in over-delivery of insulin and hypoglycemia.

All system components, including the pump, transmitter, and sensor, must be removed prior to being screened with a full-body scanner. To avoid system removal, request an alternative screening method, if necessary.

•     Carry the Medical emergency card provided with the device when traveling. The Medical emergency card provides critical information about airport security systems and pump use on an airplane. Not following the guidance on the Medical emergency card may result in serious injury.

Waterproof capabilities

•     The pump is waterproof at the time of manufacture and when the reservoir and tubing are properly inserted. It is protected against the effects of being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours.

•     If the pump is dropped, hit against a hard object, or otherwise damaged, the waterproof characteristics of the outer casing of the pump may be compromised. If the pump is dropped or might be damaged, carefully inspect it to confirm that there are no cracks before exposing the pump to water.

•     This waterproof capability rating applies only to the pump.

•     If water may have entered the pump or other pump malfunction is observed, check BG and treat high BG as necessary using an alternative source of insulin. Contact 24-Hour Technical Support for further assistance, and consult a healthcare professional about high or low BG levels or with any other questions about care.

Electrostatic discharge

•     Very high levels of ESD can result in a reset of the pump’s software and a pump error alarm. After clearing the alarm, confirm that the pump is set to the correct date and time, and that all other settings are programmed to the desired values. Following a pump reset, the SmartGuard feature will be unavailable for five hours to allow active insulin to be updated.

•     For more information on pump alarms, see Pump alarms, alerts, and messages, page 295. Contact 24-Hour Technical Support with any problems entering pump settings.

Extreme temperatures

Exposure to extreme temperatures can damage the device. Avoid the following conditions:

•     Pump storage temperature above 122 °F (50 °C) or below −4 °F (−20 °C).

•     Pump operating temperature above 98.6 °F (37 °C) or below 41 °F (5 °C). Insulin solutions freeze near 32 °F (0 °C) and degrade at temperatures higher than 98.6 °F (37 °C). In cold weather, wear the pump close to the body and cover it with warm clothing. In a warm environment, take measures to keep the pump and insulin cool.

•     Do not steam, sterilize, autoclave, or otherwise heat the pump.

 

Skin care products

Some skin care products, such as lotion, sunscreen, and insect repellents, can damage the plastic in the pump case. After using skin care products, wash hands prior to handling the pump. If a skin care product comes into contact with the pump, wipe it off as soon as possible with a damp cloth and mild soap. For instructions on cleaning the pump, see Cleaning the pump, page 285.

Infusion sets and sites, sensor, transmitter, and meter

Refer to the corresponding device user guide for all warnings, precautions, and instructions relating to the device. Failure to reference the corresponding device user guide can result in minor injury, or damage to the device.

Adverse reactions

Refer to the sensor user guide for adverse reactions related to sensor use. Failure to reference the sensor user guide may result in minor injury, or damage to the sensor.